Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

A total 6421 patients were enrolled in the study. Of these, 5598 were randomized (2807 to apixaban and 2791 to acetylsalicylic acid). Most (435) of the patients who were not randomized (823) no longer met study criteria. Of those randomized, 5578 received treatment (2798 with apixaban, and 2780 with acetylsalicylic acid).

Reporting Groups

Description

Apixaban, 2.5 or 5 mg Twice Daily

Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.

Acetylsalicylic Acid, 81-324 mg Once Daily

Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Apixaban, 2.5 or 5 mg Twice Daily

Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.

Acetylsalicylic Acid, 81-324 mg Once Daily

Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion

Total

Total of all reporting groups

Baseline Measures

Apixaban, 2.5 or 5 mg Twice Daily

Acetylsalicylic Acid, 81-324 mg Once Daily

Total

Number of Participants
[units: participants]

2807

2791

5598

Age
[units: years]Mean ± Standard Deviation

69.7
± 9.44

70.0
± 9.71

69.9
± 9.58

Age, Customized
[units: Participants]

< 65 years

855

865

1720

>=65 but <75 years

1049

938

1987

>=75 years

903

988

1891

Gender
[units: participants]

Female

1147

1174

2321

Male

1660

1617

3277

Race/Ethnicity, Customized
[units: participants]

American Indian or Alaska Native

6

6

12

Asian

541

544

1085

Native Hawaiian or Other Pacific Islander

3

1

4

Black or African American

10

26

36

White

2221

2178

4399

Other

26

36

62

Number of Participants by Number of Risk Factors for Stroke
[units: Participants]

1 or fewer

1085

1077

2162

2 or more

1722

1714

3436

Number of Participants With Risk Factors for Stroke
[1][units: Participants]

Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ]

Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period [ Time Frame: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ]

Event Rates of Major Vascular Events (Stroke/Systemic Embolism, Myocardial Infarction, Death) in the Intended-treatment Period [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ]

Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period [ Time Frame: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010 ]

Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ]

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ]

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ]

Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.

Acetylsalicylic Acid, 81-324 mg Once Daily

Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

On May 28, 2010, after a planned interim analysis for efficacy, the Data Monitoring Committee recommended early termination due to apixaban's superior efficacy over ASA, with an acceptable safety profile. The open-label phase is ongoing.